The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved a sixth COVID-19 vaccine, after the product by French pharmaceutical company Valneva was found to meet the required safety, quality and effectiveness standards.
The UK’s independent medicines regulator is the first in the world to approve the Valneva vaccine which becomes the sixth COVID-19 vaccine to be granted an MHRA authorisation.
It is also the first, whole-virus inactivated COVID-19 vaccine to gain regulatory approval in the UK. With this type of vaccine, the virus is grown in a lab and then made completely inactive so that it cannot infect cells or replicate in the body but can still trigger an immune response to the COVID-19 virus. This process is widely used already in the production of flu and polio vaccines.
Dr June Raine, MHRA Chief Executive, said: “Our approval of the COVID-19 vaccine made by Valneva today follows a rigorous review of the safety, quality and effectiveness of this vaccine, and expert advice from the government’s independent scientific advisory body, the Commission on Human Medicines.”
Professor Sir Munir Pirmohamed, Chair of the independent Commission on Human Medicines, said: “The independent Commission on Human Medicines and its COVID-19 Expert Working Group has carefully considered the available evidence are pleased to say that we have advised that the benefit risk balance is positive. The vaccine is approved for use in people aged 18 to 50 years, with the first and second doses to be taken at least 28 days apart.”
Each type of vaccine has a different pattern of antibody response over time. For the Valneva vaccine, two doses are required before a robust antibody response is raised. This means that people will need to be made aware that protection will only start after two doses.
The storage temperature for the Valneva vaccine – of 2°C to 8°C – is similar to that of a domestic fridge, making it appropriate for use in countries where storage at very low temperatures is not possible.
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “We are extremely pleased with this new authorization and would like to thank the MHRA for their trust and confidence.
“VLA2001 is the only inactivated whole virus COVID-19 vaccine approved in the UK and this authorization could pave the way for the availability of an alternative vaccine solution for the UK population.
“We continue to receive messages every day from people who are looking for a more traditional vaccine approach.
“We believe that this new approval could also lead to additional marketing authorizations in other regions of the world.
“I would like to personally thank all the people who have been supporting us in this endeavour and our internal teams for all their hard work.”
(Lead image: Valneva)
Health board lifts visiting restrictions at Glangwili and Withybush hospitals
Hywel Dda University Health Board has confirmed that restrictions for people visiting patients will be lifted in Glangwili and Withybush hospitals from Wednesday 20 July 2022.
Visiting to Bronglais Hospital, Prince Philip Hospital and community hospitals remain open, by appointment only.
The health board are advised that it will still be a requirement to wear masks in Glangwili, Prince Philip and Withybush hospitals.
Mandy Rayani, Director of Nursing, Quality and Patient Experience, said: “Last week we had to make the decision to extend measures at Glangwili Hospital in addition to Withybush Hospital to reduce the risk to our patients and staff and we thank people for their support and co-operation.
“We can all continue to take protective measures to reduce the risk of transmission of COVID-19 to protect vulnerable people and the NHS.
“We strongly advise anyone in our locality who has the classic symptoms, or who suspects they may have COVID-19 to isolate and take an LFD test. If positive, we urge people to isolate – this will help you to rest and recover while protecting others from risk of transmission.”
(Lead image: Google Maps)
Mask wearing reinstated at Llanelli’s Prince Philip Hospital
Hywel Dda University Health Board have said that all staff and visitors to Prince Philip Hospital must wear face masks (unless exempt) with immediate effect following the latest review of prevalence of COVID-19 in the community.
This follows the decisions made last week to reinstate mask wearing at Glangwili Hospital and both mask wearing and visiting restrictions at Withybush Hospital.
The health board have said that visiting will continue in general at Glangwili and Prince Philip hospitals following the latest review of case numbers but local ward restrictions are in place so please contact the ward to arrange your visit in advance
Mandy Rayani, Director of Nursing, Quality and Patient Experience for Hywel Dda UHB, said: “Wearing a surgical mask or face covering and keeping a physical distance when attending a hospital or medical facility will help protect our most vulnerable patients and service users.
“We are grateful for the ongoing support and efforts of our communities to stop the spread, particularly around more vulnerable people.
“These measures will be continually reviewed, and as soon as it is safe to do so, we will ease these restrictions.”
The health board is stressing the continued importance of the behaviours known to reduce transmission of COVID-19 and other infectious diseases, and the different requirements in place in health and social care settings.
Mandy, added: “Isolating if we have symptoms of COVID-19, or other infectious diseases, is one of the most important things we can do to prevent the onward spread and break the chain of transmission.
“We strongly encourage anyone in our locality who has the classic symptoms, or who suspects they may have COVID-19 to isolate and take an LFD test. If positive, we urge people to continue with the same isolation guidance that has been in place – this will help you to rest and recover and protect others from risk of transmission.”
Later this week, the Welsh Government will update its vaccine strategy with details of the next booster dose in the autumn.
The Chief Medical Officer for Wales, Sir Frank Atherton said:
“The vaccine is the best way to protect yourself and others from coronavirus. While the vaccine does not completely stop transmission it offers protection against serious illness and reduces the risk of hospitalisation.
“You can still get the vaccine if you haven’t had your full course, or you were too ill to get your spring booster and I would encourage parents to think about getting the vaccine for their children over the summer months to help minimise any disruption to their education during the autumn and winter terms.”
(Lead image: Hywel Dda NHS)
Study reveals factors affecting public attitude towards Covid and the new normal
Partygate, a lack of media coverage and the perception that the virus is now milder could all affect future compliance with Covid guidance.
New Swansea University research has revealed that though many people feel life is now back to normal, a minority are still socially distancing and feel like they have been reconditioned to be more cautious.
The study, by Dr Simon Williams and Dr Kimberly Dienes of the School of Psychology, explored people’s current behaviours around Covid-19, including mask wearing, social distancing, testing and isolation.
It also looked at people’s views on future booster jabs, including whether they felt they would want one. The study went on to ask if they were likely to follow rules or guidance if another variant emerged this autumn.
It found most people were willing to take steps in future to reduce passing on Covid or other viruses, however a number felt they would only distance or wear masks if the situation was “serious” and “people started dying again”. Many felt that the Partygate and other controversies over political figures breaking Covid rules would affect compliance with future rules.
The study has been published by PsyArXiv , a site used by researchers to share new findings on timely issues before they have been peer-reviewed for publication in a journal.
It found a lack of media coverage of the pandemic, the war in Ukraine and the cost-of-living crisis were big factors in why people felt they weren’t thinking about Covid as much.
There was a common perception that new Omicron variants are milder than previous variants, which has reduced concern, with the use of face masks having been de-normalised.
The study found that people’s willingness to test is high. However, knowing when to test, and willingness to buy tests was variable.
The desire to protect the NHS did not feature at all as a motivation to take actions to reduce transmission; and,
There was a modest appetite for future booster jabs among those who had been triple-jabbed. However, a number suggested they would only be likely have a further booster if officially recommended or invited.
The research involved online focus groups with 28 participants between 15th and 30th June 2022.
Dr Williams said: “Our study shows that many people feel as though things have returned to normal, and they haven’t been thinking about Covid much, if at all, recently. This is understandable – it’s been a hard two years and people are entitled to enjoy the relative freedoms, compared to earlier in the pandemic.
“However, it is also concerning, as we are currently in the middle of one wave, with new variants and new waves likely to emerge in autumn and winter. The challenge is to find a more balanced, sustainable way forward, where we can keep some protective behaviours, while looking to governments and organisations to provide broader supports – like good ventilation, hybrid working, free testing, and better sick pay.
“Our study has a number of implications. It’s important to provide adequate risk communication. It’s important not to unduly worry people about the pandemic, but similarly it’s important that people are aware of the ongoing impacts. The lack of recent media coverage, and the way some in Government have been taking about ‘living with the virus’ in ‘post-pandemic’ UK, may have provided too much of a false sense of security.
“Finally, trust has been shown to play a big role in how motivated people are to follow guidance and rules. Partygate has severely dented many people’s confidence in Government’s handling of the pandemic, as well, potentially their willingness to do things like wear masks or socially distance in the future, if required.
“There are some worrying signs that in the future, if further guidance or even rules come back into play, people may not be as willing to comply, which of course will have impacts on transmissions, hospitalisations and ultimately NHS capacity.”
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